The Binding Site Group Ltd. today announced it has entered a collaboration agreement with Mayo Clinic to develop a novel clinical laboratory test for the identification and accurate measurement of monoclonal proteins present in B-cell diseases. The two organizations want to improve the testing, diagnosis and monitoring of patients with multiple myeloma and related conditions.

For more than two decades, The Binding Site and Mayo Clinic have been involved in collaborative activities. The evolution of this relationship sees a unification of The Binding Site’s antibody- and assay-development expertise with the clinical excellence of Mayo Clinic and Mayo’s recently patented approach to improving multiple myeloma patient monitoring.

The new technology, which is based on antibody-antigen interactions and mass spectrometry, will mean that, for the first time, all intact immunoglobulin multiple myeloma patients’ proteins can be identified, classified and quantified simultaneously. The technology relies on both institutions’ core expertise and unifies their commitment to improving multiple myeloma patient monitoring. The collaboration also uses patents owned by Mayo and The Binding Site, and several patents jointly held by both organizations.

The Binding Site has been at the forefront of the fight against multiple myeloma and other B-cell disorders. The company’s Freelite® assay is the only serum free-light-chain assay approved by the U.S. Food and Drug Administration to help diagnose and monitor patients with B-cell disorders — now established as the standard of care in the International Myeloma Working Group’s guidelines for diagnosis, monitoring and prognosis of the disease, as well as being incorporated into many country-specific guidelines around the globe. Also, the invention of The Binding Site’s Hevylite™ assay has added significant value in understanding intact immunoglobulin multiple myeloma patient responses, and together, these assays have been the subject of some 650 peer-reviewed journal articles. The commitment to this new relationship underlines The Binding Site’s ethos of never standing still in the fight against myeloma.

The output of this collaboration will build on The Binding Site’s core expertise in understanding methods to identify and measure monoclonal immunoglobulins and will revolutionise the approach in the clinical laboratory. The test will reduce subjective interpretation, improving diagnosis and monitoring of these patients, as well as improving the laboratory workflow.

“The Binding Site’s roots are founded in clinically relevant science, and one of our key attributes is the ability to develop and produce antibodies and corresponding in vitro diagnostic tests for diseases that are difficult to identify or measure accurately,” says Charles de Rohan, CEO, The Binding Site. “This agreement further demonstrates our commitment to improving patient care by providing laboratories across the world with new and improved diagnostic techniques. Mayo Clinic and The Binding Site share the philosophy of keeping the patient at the centre of our work.”

“For many years, The Binding Site and Mayo Clinic have collaborated in pursuit of improved diagnostic techniques, especially in the areas of monoclonal proteins and immunoglobulin components,” says William Morice, II, M.D., Ph.D., chair of Mayo’s Department of Laboratory Medicine and Pathology and president of Mayo Medical Laboratories. “At the end of the day, our collaborative efforts are always focused on the clinical laboratory implementation of scientific advancements for the benefit of our patients and their families.”

Specific terms of the agreement have not been disclosed, though The Binding Site is establishing a research and development facility in Rochester, Minnesota, where Mayo Clinic is based.

Mayo Clinic has a financial interest in the patents licensed to The Binding Site referenced in this news release.